Other defendants in these cases as originally filed 1

include the duPont Hospital and other doctors and medical

professionals.

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

PAUL SVINDLAND, et al. : CIVIL ACTION

:

v. :

:

THE NEMOURS FOUNDATION, :

et al. : NO. 05-417

________________________________________________

ROBERT DADDIO, et al. : CIVIL ACTION

:

v. :

:

THE A.I. DUPONT HOSPITAL FOR :

CHILDREN OF THE NEMOURS :

FOUNDATION, et al. : NO. 05-441

MEMORANDUM

McLaughlin, J. May 18, 2009

The plaintiffs in these medical malpractice cases are

the parents of infants who died at some point after undergoing

open-heart surgery at the A.I. duPont Hospital for Children (“the

duPont Hospital”). The defendants that remain are the Nemours

Foundation, which operated the Nemours Cardiac Center at the

duPont Hospital, and William I. Norwood, M.D. (“Dr. Norwood”),

who performed the surgeries. The plaintiffs allege, among other 1

things, that the technique used by Dr. Norwood to cool the

children prior to their surgeries violated the standard of care

and thus constitutes malpractice. 

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 1 of 26
 The defendants’ motion for a protective order was filed in 2

both the Svindland and Daddio cases. The plaintiffs did not,

however, dual-file their motion to compel. Nonetheless, the

Court’s decision and rationale for the CHOP data issue shall

apply to both cases.

2

This memorandum concerns three pretrial evidentiary

motions filed by the parties. First, the defendants have moved,

in the Svindland case, to preclude the plaintiffs from

introducing evidence related to the morbidity and mortality rates

of Dr. Norwood’s patients, of other patients treated at the

duPont Hospital, or of any other patients that are not Ian

Svindland. Second, the defendants have moved for a protective

order related to subpoenas that the plaintiffs directed to the

Children’s Hospital of Philadelphia (“CHOP”) and Dr. James Goin,

a statistician at CHOP, to obtain certain raw data underlying

publications of studies done at CHOP (the “CHOP data”). Third,

the plaintiffs have moved to compel CHOP and Dr. Goin to produce

the CHOP data. For the reasons herein stated, the defendants’ 2

motions are granted and the plaintiffs’ motion is denied.

I. Background and Procedural Posture

Ian Svindland was born with a congenital heart defect

known as a ventricular septal defect (“VSD”). A VSD is a hole in

the wall separating the two pumping chambers of the heart. Dr.

Norwood operated on Ian on June 25, 2003. After six hours of

surgery, Ian’s heart began to fail, and after eighteen hours, he

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 2 of 26
3

was placed on a heart-lung bypass machine for support. Ian’s

heart continued to fail, and eventually, other organs did as

well. Ian died on July 14, 2003.

Michael Daddio was also born with congenital heart

defects, including “hypoplastic left heart syndrome.” On June 7,

2001, Dr. Norwood performed the first of three scheduled

surgeries to correct Michael’s heart defects. The second was

performed on November 9, 2001. At some point after the second

surgery, Michael developed persistent pleural effusions, which

are liquid buildups surrounding the lungs. Michael died on July

23, 2003. 

During the surgeries on both infants, Dr. Norwood

utilized a technique known as “deep hypothermic circulatory

arrest” (“DHCA”), in which the body is cooled to a certain

temperature, blood is removed and stored, and the surgeon

operates in a bloodless field on a heart that does not beat. 

Cooling serves the purpose of reducing the amount of oxygen

required by the body’s organs in the absence of blood flow.

These cases were initially assigned to the Honorable

Berle M. Schiller of the Eastern District of Pennsylvania. Upon

agreement of the parties, these two cases were consolidated with

other cases filed against the defendants for the purposes of

discovery. Pursuant to a stipulation filed by the parties, Judge

Schiller would sit as the “discovery judge,” and the parties

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 3 of 26
4

would agree which, if any, disputes would be heard before Judge

Schiller as the discovery judge, and which would be heard by

Judge Schiller as the trial judge for the Svindland and Daddio

cases. See Svindland Docket No. 20; Daddio Docket No. 21.

The Svindland case proceeded to trial in May 2007. 

Prior to trial, the parties filed several evidentiary motions

relating to the exclusion of certain data and expert testimony. 

The plaintiffs also sought to enforce subpoenas for the CHOP

data. The Court precluded the plaintiffs from presenting

evidence at trial related to the mortality of Dr. Norwood’s

patients or other patients of the duPont Hospital. It also

quashed the subpoenas related to the CHOP data.

At trial, the Svindlands concentrated on two issues. 

They claimed that Dr. Norwood only cooled Ian for six minutes,

which was not long enough to protect Ian’s organs, and ultimately

caused his death. They also claimed that the information given

to them in order to constitute informed consent did not acquaint

them with the mortality risks for Ian’s operation.

The jury ruled for the defendants. It found that Dr.

Norwood was negligent. However, the jury also found that the

Svindlands’ proof was not adequate to establish that Dr.

Norwood’s cooling technique proximately caused Ian’s death. The

jury also found no lack of informed consent.

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 4 of 26
 The legal issues on appeal included “the admissibility of 3

mortality data introduced by one of [the Svindlands’] experts,

the enforceability of a subpoena issued to two non-parties, the

admissibility of testimony from one of the Svindlands’ prior

physicians, and the legality of one of the jury instructions.” 

Svindland, 287 F. App’x at 195 n.1. The Court of Appeals did not

decide these issues because it found that they would be better

addressed by the district court in a new trial. Id.

5

The plaintiffs appealed the jury verdict to the United

States Court of Appeals for the Third Circuit, challenging

several of the Court’s rulings, including orders quashing the

subpoenas for the CHOP data and precluding the plaintiffs from

introducing mortality evidence. The Court of Appeals vacated the

jury verdict, in part, because it could not determine on the

record before it the rationale for some of the Court’s

evidentiary rulings. See Svindland v. The Nemours Foundation,

287 F. App’x 193, 195 (3d Cir. 2008). The Court of Appeals did

not reach the merits of the legal issues that were presented on

appeal, and instead remanded the case for decision on these

evidentiary issues and for a new trial.3

The Daddio case has not yet proceeded to trial. 

Although the case was set to be tried in July 2007, it did not

proceed as scheduled. After the Court of Appeals vacated the

jury verdict in Svindland, both cases were reassigned to the

undersigned judge. 

The Court held an on-the-record status conference with

the parties on September 16, 2008, to isolate the issues for

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 5 of 26
6

decision in light of the Svindland appeal and to discuss

schedules for the retrial of the Svindland case and for the trial

of the Daddio case. See Svindland Docket No. 145; Daddio Docket

No. 127. After that conference, the Court issued scheduling

orders setting trial dates in both cases, as well as schedules

for the filing of pretrial motions. See Svindland Docket No.

149; Daddio Docket No. 131. 

Shortly after the conference, the parties filed various

evidentiary motions. These include: (1) the defendants’ motion

to preclude the plaintiffs from introducing comparative morbidity

or mortality data at trial (“Defs.’ Mot. to Preclude,” Svindland

Docket No. 148); (2) the defendants’ motion for a protective

order relating to the subpoenas of the CHOP data (“Defs.’ Mot.

for P.O.,” Svindland Docket No. 147; Daddio Docket No. 130); and

(3) the plaintiffs’ motion to compel the production of the CHOP

data (Svindland Docket No. 150).

II. Discussion

The parties’ motions concern two sets of data. The

first set of data includes evidence of morbidity and mortality

rates for the patients of Dr. Norwood, the surgeon in this case,

and for other patients at the duPont hospital and at other

hospitals who have undergone the types of cardiac surgery at

issue. The second set of data consists of raw data that served

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 6 of 26
7

as the basis for two publications of studies done at CHOP. As

the Court understands it, the plaintiffs seek this latter

evidence so that their expert can independently analyze the data

and further evaluate whether the cooling technique used by Dr.

Norwood created a heightened risk of adverse outcomes. The Court

will address each set of data in turn.

A. Morbidity and Mortality Data

The defendants’ motion to preclude mortality data

pertains to two forms of evidence. First, the defendants argue

that the testimony of the plaintiffs’ expert, Dr. Robert L.

Hannan, is inadmissible under Daubert because it is based on

scientifically unreliable data and methods. Second, the

defendants seek to preclude the defendants from introducing any

evidence of morbidity or mortality rates more generally. Such

evidence, they argue, is irrelevant, unreliable, prejudicial, and

based on hearsay. The Court agrees with the defendants, and will

grant the defendants’ motion to preclude the plaintiffs from

introducing either form of evidence at trial.

1. The Admissibility of Dr. Hannan’s Testimony

The defendants expect that the plaintiffs will try to

introduce expert testimony to prove that Dr. Norwood’s mortality

rate was “too high” and that it was caused by his cooling

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 7 of 26
 Dr. Jacobs is a cardiovascular and thoracic surgeon, the 4

surgical director of heart transplantation at the Congenital

Heart Institute of Florida, and a clinical associate professor at

the University of South Florida. Dr. Jacobs is also a member of

the Society of Thoracic Surgeons (“STS”), the largest

professional organization of cardiac and thoracic surgeons in the

country. The STS has developed a database of patient outcomes,

which is the largest such database in North America. Dr. Jacobs

has chaired the STS congenital heart surgery database committee

since 2006.

 Dr. Newburger is in the Department of Cardiology at 5

Children’s Hospital Boston, and is the Department’s Associate

Chief for Academic Affairs. She is also the Commonwealth

Professor of Pediatrics at Harvard Medical School. 

8

technique. This testimony will come from the plaintiffs’ expert

witness, Dr. Robert L. Hannan. As the Court understands it, Dr.

Hannan will compare data from the Delaware Health Statistics

Center (the “DHSC data”) to data from Children’s Hospital Boston

(the “Boston data”). The Court finds that Dr. Hannan’s testimony

and report comparing these data are inadmissible under Daubert.

The defendants argue that Dr. Hannan’s testimony is

inadmissible under Daubert v. Merrell Dow Pharmaceuticals, Inc.,

509 U.S. 579 (1993), for three reasons: (1) the DHSC data are

unreliable; (2) the Boston data are unreliable; and (3) the

method employed by Dr. Hannan to compare these two sets of data

is unreliable. 

The Court held a hearing on the parties’ evidentiary

motions on March 11, 2009. At the hearing, the defendants

presented the testimony of two live witnesses, Dr. Jeffrey P.

Jacobs and Dr. Jane Newburger. The defendants also submitted 4 5

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 8 of 26
 Dr. Pollack is currently the chief medical officer and 6

chief academic officer of the Phoenix Children’s Hospital.

9

to the Court the videotaped deposition of Dr. Murray M. Pollack.6

These witnesses presented testimony relating to the reliability

of the data and method used by Dr. Hannan. The plaintiffs did

not present any witnesses.

For the reasons argued by the defendants, and based on

the testimony they presented at the hearing, the Court agrees

that the DHSC and Boston data are unreliable, and that the method

used by Dr. Hannan to compare the two is also unreliable. Dr.

Hannan’s testimony and report, insofar as they pertain to the

mortality issue, are inadmissible under Daubert.

a. The DHSC Data

The defendants argue that the DHSC data are not

scientifically reliable for several reasons. First, the data are

not risk-adjusted - i.e., they do not reflect for other factors

that might increase or decrease the likelihood of death for

particular patients. Second, the data - which are primarily in

the form of administrative billing codes - do not differentiate

between surgeons, do not identify patient co-morbidities - i.e.,

whether the patient may have also had other, unrelated diseases -

and do not reveal the complexities of the underlying heart

defects. 

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 9 of 26
10

At the March 11 hearing, the defendants’ witnesses

corroborated these arguments. Dr. Jacobs testified that the DHSC

data relied upon by Dr. Hannan are gleaned from Delaware State

Health Department medical records, and utilize International

Classification of Disease Codes, Version 9 (“ICD-9 codes”). The

primary function of ICD-9 codes, according to Dr. Jacobs, is not

to facilitate the prediction of outcomes in particular cases, but

rather, to facilitate billing.

 Dr. Jacobs stated that several publications have

studied the reliability of ICD-9 codes as a source of mortality

rates, and that these codes should not be used to predict

outcomes. He also stated that any use of these codes for

outcomes analysis is subject to major errors and

misinterpretation. Dr. Jacobs further testified that ICD-9 codes

are not assigned by heart surgeons, but rather, by billing clerks

who have never seen the patients. This arrangement creates the

potential for misclassification of operations and procedures. 

According to the defense witnesses, the issue of

nomenclature is of significance to outcomes analysis. Dr. Jacobs

stated that the first step to being able to compare outcomes

between two centers or databases is that each must use the same

terminology. If the data are being used to analyze patient

outcomes in particular, that nomenclature should be clinical

nomenclature - as opposed to billing nomenclature. In other

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 10 of 26
 This conclusion is supported by medical literature 7

submitted by the defendants. One article in particular, entitled

“The Importance of Nomenclature for Congenital Cardiac Disease:

Implications for Research and Evaluation,” specifically concludes

that analyses based on the use of ICD-9 codes may have

“substantial misclassification of congenital heart disease. 

Isolating the major defect is difficult, and certain codes do not

differentiate between variants that are clinically and

developmentally different.” See Jacobs Ex. 3.

11

words, the name assigned to a procedure by a billing clerk, who

may not understand the differences between particular procedures,

is not as reliable from an outcomes standpoint as the name

assigned to a procedure by a performing surgeon. 

7

Dr. Pollack further explained that the use of ICD-9

codes in the context of VSDs can be misleading. He stated that

although a “VSD” can be an isolated defect, it can be a “small

isolated defect,” or a “large isolated defect.” Thus, the coding

of a defect as a “VSD” in an ICD-9 code “does not tell the whole

story.” See Pollack Dep. Tr. 13-14, 3/6/2009.

In contrast to ICD-9 codes, Dr. Jacobs stated that

there is another set of codes called the International Pediatric

and Congenital Cardiac Code (“IPCCC”). The IPCCC is a clinicalbased nomenclature that was created by a multi-institutional,

multi-national group of cardiologists and cardiac surgeons. The

coding for the IPCCC is done by healthcare professionals that

actually take care of the patients. These codes, which are

entered into the STS database, are monitored by “database police”

who ensure that the database is complete and accurate. On the

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 11 of 26
12

other hand, the ICD-9 codes contained in the DHSC data have no

such verification mechanism in place.

Based on this evidence, which the plaintiffs have not

contradicted, the Court agrees that the DHSC data are not

scientifically reliable.

b. The Boston Data

The defendants argue that the data from Children’s

Hospital Boston are also unreliable. These data, taken from the

hospital’s website, also do not identify the operating surgeon or

any patient co-morbidities. The website does not state how it

defines terms such as “survival” or “VSD,” and what cooling

techniques were used in any of the cases reported. 

At the March 11 hearing, the defendants presented

evidence to show that the data gleaned from the Children’s

Hospital Boston website are scientifically unreliable. As stated

by Dr. Jacobs, one problem with the Boston website is that it

only reported thirty-day mortality. That is, if a baby died on

the thirty-first day following a procedure, that baby is still

counted as a survivor. The website was not created for

institutional comparison of outcomes, but rather, to share

information with the people reading the website. The website

itself states: “Because hospitals present data differently and

because of the uniqueness of each child’s situation, it is

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 12 of 26
 As Dr. Jacobs explained, the STS has developed another 8

method of risk-stratification for congenital cardiac surgeries. 

As explained by Dr. Jacobs and Dr. Pollack, this method, known as

“Aristotle,” requires examination of “very detailed” diagnostic -

as opposed to administrative - information. Dr. Jacobs further

13

important that statistics and outcomes are fully explained. We

are happy to speak with parents regarding Children’s Hospital

Boston’s outcomes anytime.” See Defs.’ Mot. to Preclude Ex. F.

For the reasons advanced by the defendants and their

witnesses, the Court finds that the Boston data are not

scientifically reliable.

c. The Reliability of Dr. Hannan’s Method

Finally, the defendants argue that even if the DHSC and

Boston data were risk-adjusted and reliable, there is no

scientific basis to conclude that a lower mortality rate at one

hospital is evidence of negligence or causation. In other words,

the method used by Dr. Hannan to compare the DHSC and the Boston

data is unreliable.

To compare the data, Dr. Hannan utilized a method known

as the Risk-Adjustment in Congenital Heart Surgery (“RACHS-1")

method. RACHS-1 is a system of complexity stratification of

children’s heart surgeries. This method classifies a procedure

into one of six categories, based upon the relative level of

riskiness of the procedure, as agreed upon by a panel of

experts.8

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 13 of 26
explained that there is a group of investigators that is in the

process of discussing the potential of merging the RACHS-1 method

and the Aristotle method into a “RACHS-2” method. Dr. Jacobs is

a member of that group.

 The defense witnesses each stated that even within the 9

category of “VSDs,” not every VSD is the same, and that just

because an infant has a VSD, that does not mean that the same

treatment should be applied to each. Dr. Pollack explained at

his deposition that the VSD patients examined by Dr. Hannan were

“not a group of simple VSD patients.” In particular, at least 92

of the 101 patients had at least one secondary diagnosis, 76 with

at least two secondary diagnoses, 64 with at least three, 48 with

at least four, and 38 with at least five. See Pollack Dep. Tr.

13-14, 3/6/2009.

14

Dr. Newburger is one of the eleven members of a panel

who developed the RACHS-1 method. Both she and Dr. Jacobs stated

that Dr. Hannan’s use of RACHS-1 was improper. They both

testified that RACHS-1 was created to help medical institutions

benchmark their performance from a mortality standpoint among

institutions nationwide. In other words, RACHS-1 was designed to

compare the whole body of work of a given program to a national

standard for each classification group. It was not meant to

compare one surgery to another surgery, or to look at the

performance of an individual surgeon for a given operation. 

9

RACHS-1 also cannot be utilized to draw a conclusion about Dr.

Norwood’s performance by simply comparing DHSC billing codes with

the data on the Boston website. 

Dr. Hannan’s testimony is inadmissible under Daubert. 

Under Daubert and Federal Rule 702, an expert’s testimony must be

based on sufficient facts or data and must be the product of

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 14 of 26
 For example, Dr. Hannan testified that “we never had a 10

baby . . . that died” and that “we haven’t had [a baby with VSD]

die.” See Trial Tr. 20, 22, Defs.’ Mot. to Preclude Ex. B. He

also stated that the technique used by Dr. Norwood “resulted in a

ten times higher incidence of seizures post-operatively than

other potential techniques” and “that the incidence of death

would be increased.” Id. at 52. 

15

reliable principles and methods. An expert’s opinion must also

be based on a reliable application of the principles and methods

to the facts of the case. 

Dr. Hannan’s testimony does not meet the Daubert

standard. The expert testimony presented by the defendants at

the March 11 hearing clearly establishes that use of the data by

Dr. Hannan is not based on scientifically reliable evidence or on

a reliable application of the methods used to the facts of the

case. This testimony is therefore inadmissible under Daubert.

2. Evidence of Mortality Generally

The defendants expect the plaintiffs will also try to

introduce evidence of morbidity and mortality by introducing

isolated pages of medical records of other patients who had poor

outcomes or who died following pediatric open-heart surgery. In

addition, at the first trial of this case, counsel for the

plaintiff attempted to question Dr. Norwood about the outcomes of

prior surgeries, and Dr. Hannan referred to his and to Dr.

Norwood’s mortality rates. The defendants have moved to 10

preclude the plaintiffs from introducing any such evidence or

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 15 of 26
16

testimony, or from engaging in lines of questioning that would

lead to the production of such testimony. In other words, they

wish to exclude all evidence referring to the morbidity and

mortality rates of Dr. Norwood’s other patients, of other

patients at the duPont hospital, or of patients of other doctors

at other hospitals. 

The defendants have four main arguments as to why the

Court should preclude this evidence. Their first argument is

that such evidence is not relevant to show whether Dr. Norwood

was negligent in this case, as it will not establish causation or

a standard of care. They state that what the correct standard of

care is will not be made more or less likely by mere comparison

of mortality rates without consideration of other factors. As

for causation, they argue that the course of Ian’s treatment was

the same regardless of whether Dr. Norwood or other surgeons

performed operations on other patients who died, and that a

comparison of mortality rates at other institutions - especially

where these rates are not properly risk-adjusted - will also not

provide evidence about the causes of the underlying deaths.

The defendants’ next argument for preclusion is that

any probative value of this evidence is outweighed by the danger

of unfair prejudice. The evidence, they contend, will be taken

out of context by the jurors, who may believe that the deaths of

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 16 of 26
17

Dr. Norwood’s other patients were due to negligence, and thus

decide the case on an improper basis.

Third, the defendants argue that mortality evidence -

i.e., evidence of deaths in prior surgeries - is analogous to

prior bad act evidence that is inadmissible under Rule 404(b). 

They further argue that, in most jurisdictions, evidence of a

physician’s prior surgical or malpractice history cannot be used

to prove that the surgical team acted in accordance with these

prior acts. See Defs.’ Mot. to Preclude 15 (citing, e.g., Weil

v. Seltzer, 873 F.2d 1453 (D.C. Cir. 1989)).

The defendants’ final argument is that this evidence

will confuse the jury and waste judicial resources. The

introduction of such evidence, they contend, will lead to

collateral mini-trials regarding the medical histories and other

circumstances in prior cases and prior outcomes.

Although the Court cannot say at this stage that

mortality evidence will never be appropriate in particular lines

of examination at trial, the Court agrees with the defendants

that such evidence is generally not relevant to the elements of

the plaintiffs’ malpractice claim. See supra note 4. In

particular, the evidence will not tend to establish causation or

the standard of care. Even if mortality rates might seem

relevant to the plaintiffs’ informed consent claims, the

plaintiffs have not persuaded the Court that the mortality data

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 17 of 26
18

that they would seek to introduce have taken into account comorbidities or have otherwise been risk-adjusted so as to be

relevant to the surgeries at issue. The Court also believes that

such evidence may confuse or otherwise be taken out of context by

the jurors, thus creating the risk of unfair prejudice to the

defendants. The introduction of this evidence might lead to a

confusing and lengthy trial. 

The Court will grant the defendants’ motion to preclude

this evidence. The plaintiffs may not introduce evidence or

testimony pertaining to the morbidity or mortality rates of Dr.

Norwood’s patients or of other doctors’ patients. They shall

also refrain from engaging in lines of questioning that will lead

to the production of such testimony.

B. CHOP Data

On September 3, 2008, the plaintiffs served subpoenas

to obtain the raw data underlying publications of studies done at

CHOP, in order to allow their expert to independently evaluate

the data and offer an opinion on whether the cooling technique at

issue increased the risk of adverse surgical outcomes. These

subpoenas were served on CHOP and on Dr. James Goin, a CHOP

statistician. The defendants have moved for a protective order

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 18 of 26
 The Court previously denied the plaintiffs’ motion to 11

enforce the subpoenas in the Daddio case and their motion for

reconsideration of that decision. See Daddio Docket No. 98. By

order dated March 23, 2007, those decisions were incorporated

into the Svindland case. See Svindland Docket No. 98.

19

over this data, and the plaintiffs have moved for an order

compelling the production of the data.11

The CHOP data are raw data that served as the basis for

two articles, “Allopurinol Neurocardiac Protection Trial in

Infants Undergoing Heart Surgery Using Deep Hypothermic

Circulatory Arrest” (“Allopurinol”) and “Risk of Seizures in

Survivors of Newborn Heart Surgery Using Deep Hypothermic

Circulatory Arrest” (“Risk of Seizures”). The “Allopurinol”

article is a pharmacologic study of the efficacy of the drug,

Allopurinol, in preventing adverse neurological outcomes in

infants who underwent DHCA. This article did not describe any

relationship between cooling durations and outcomes.

The “Risk of Seizures” article is a study of the

variables associated with postoperative neurological events in

survivors of congenital heart surgery. One of the variables

examined was DHCA time. The study found that DHCA time “was not

significantly associated with” the occurrence of acute

neurological events. See Defs.’ Mot. for P.O. Ex. F at 595.

According to CHOP, which filed a third-party opposition

to the plaintiff’s motion to compel, the data for these studies

was collected in accordance with an NIH contract that authorized

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 19 of 26
 CHOP notes that authorship in biomedical journals is 12

often conferred merely for use of a doctor’s patients in a

research study. CHOP Opp. to Pls.’ Mot. to Compel 9 n.3

(discussing the concept of “gift authorship”).

20

CHOP to study the efficacy of Allopurinol. The patients analyzed

were treated by four different surgeons at CHOP, including Dr.

Norwood, from 1992-1997. According to the defendants and CHOP,

Dr. Norwood did not have access to this data after he left CHOP

in 1994. Although he was listed as an author of these studies,

the defendants and CHOP claim that this is merely because some of

his patients were used as test cases. The plaintiffs have not 12

disputed this point.

The defendants present five main arguments for the

protection of this data. First, they argue that the proposed

reexamination of this data by the plaintiffs’ experts will not

show what Dr. Norwood knew when he operated on Ian Svindland. 

Other than the fact that Dr. Norwood is identified as a

contributor to the two articles, there is no other connection

between Dr. Norwood and the data to suggest that he knew or

should have known that his cooling technique was beneath the

standard of care when he performed the surgeries at issue.

Second, the defendants argue that a present-day

evaluation of the CHOP data will not demonstrate what the

applicable standard of care was in 2001 or in 2003. This

standard, they contend, can be established by expert testimony,

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 20 of 26
 Throughout the course of the proceedings before this 13

Court, the plaintiffs have referred to both fifteen- and twentyminute cooling times as the standard of care. Most recently, the

plaintiffs stated that they intend to show that fifteen minutes

of cooling are necessary.

21

by reference to published guidelines, and through crossexamination at trial. The articles for which the data were

gathered did not conclude that surgeons should cool for a

particular length of time, and even if the data could be assessed

now to establish that conclusion, Dr. Norwood cannot be held

liable for failing to follow such a standard when he operated.

Third, the defendants argue that the data will not

establish either proximate or but-for causation. The

“Allopurinol” article did not discuss any relationship between

cooling duration and outcomes, and the data set involved in the

“Risk of Seizures” article had a mean cooling time of 11.5

minutes. Thus, the plaintiffs cannot establish that 15 minutes

of cooling were required using this data. Moreover, the “Risk 13

of Seizures” article itself concluded that there was no

significant association between cooling time and adverse

outcomes. As for but-for causation, the defendants argue that

even the plaintiffs’ experts previously give conflicting opinions

concerning the cause of Ian’s death or Michael’s death. For

these reasons, the CHOP data would not shed further light on the

outcome in this case.

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 21 of 26
 The defendants also argue that because the Daddio case 14

never actually proceeded to trial before Judge Schiller, the

evidentiary rulings in Daddio still stand as the law of the case. 

These rulings include an order denying the plaintiffs access to

the CHOP data. See Daddio Docket No. 98. The defendants argue

that these rulings should not be overturned because there is no

new evidence or new law that would affect the issues resolved by

that ruling, and because the ruling is not clearly erroneous. 

See Defs.’ Mot. for P.O. 7-8. In light of the Court of Appeals’s

rationale for vacating the jury verdict in Svindland, the Court

will take no position on this issue at this juncture, and instead

will here decide the CHOP data issue on the merits.

22

Fourth, the defendants argue that any probative value

that this evidence might have would be outweighed by its

prejudicial impact. The jury, they contend, will confuse the new

findings of the plaintiffs’ expert with the relevant standards

from 2001 or 2003, and may, as a result, improperly decide the

case using those findings.

Fifth, the defendants argue that the plaintiffs, as

biased litigants, should not have access to confidential nonparty data, especially where they have not made a showing of

substantial need. The plaintiffs should not be permitted to

reexamine confidential data that was objectively assessed by nonbiased researchers so that they could prove the theory that they

have already decided to pursue at trial.14

CHOP has also presented several additional arguments

against the production of this data. First, it argues that peer

review is the correct process for testing scientific ideas, and

Case 2:05-cv-00417-MAM Document 185 Filed 05/19/09 Page 22 of 26
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not litigants and their biased experts reanalyzing raw research

data without any peer review.

Second, CHOP argues that even if the data were

produced, the plaintiffs could not perform a statistically valid

analysis because the data are skewed, given that too few patients

had cooling times of fifteen minutes or more. In the “Risk of

Seizures” article, for example, the majority of patients had

cooling times under thirteen minutes. CHOP also argues that the

plaintiffs have not identified an individual qualified to analyze

such complex data. It has also stated that an order requiring

CHOP to produce the data would be unduly burdensome, as it no

longer has the relevant case report forms, which were used to

collect patient information. It states that these forms would be

needed to validate the data.

Third, CHOP argues that the plaintiffs have not

demonstrated substantial need for the data, as is required to

compel production from third parties under Rule 45. Although the

plaintiffs argue that no privilege applies to medical research,

CHOP argues that the clear terms of Rule 45 apply to the data

here because they are “other confidential research information”

and also “an unretained expert’s . . . information that does not

describe specific occurrences in dispute.” CHOP Opp. to Pls.’

Mot. to Compel 16.

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Fourth, CHOP argues that federal and state privacy

protections weigh heavily against disclosure. As a preliminary

matter, the data is owned by NIH, and under the terms of the NIH

contract, the consent of both NIH and each patient in the study

would be needed. CHOP also argues that the information is

protected under the Privacy Act, and that medical privacy is a

fundamental right under the Pennsylvania Constitution. Even if

the Court were to order CHOP to produce a redacted version of the

data, CHOP also contends that production of the data would be

unduly burdensome because the effort required to redact and to

interpret the data would be vastly disproportionate to any

relevance to this action. 

Finally, CHOP argues that the production of research

data should be prohibited on public policy grounds - namely, that

scientists should be able to conduct research without fear that

raw data will be subject to subpoena and biased reinterpretation

in unrelated lawsuits. A contrary holding, CHOP claims, would

have a profound chilling effect on medical research. 

The Court agrees with the defendants and with CHOP that

the plaintiffs have not stated a reason to compel the production

of the CHOP data. The data are not relevant to show what Dr.

Norwood knew when he operated on Ian Svindland or Michael Daddio. 

Nor will they prove the applicable standard of care in 2001 or

2003. They also will not shed further light on the issues of

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proximate and but-for causation. The plaintiffs essentially seek

to have their expert duplicate the efforts of the CHOP

researchers who performed the studies and wrote the publications

at issue. However, in neither study did the researchers find a

correlation between cooling time and adverse outcomes. 

Even leaving aside policy considerations, the Court

will not allow the plaintiffs to redo the CHOP studies. The

Court finds that the benefit of doing so is outweighed by the

prejudice and burden that doing so would create for the

defendants and for CHOP. First, to the extent that the

plaintiffs’ expert reaches a conclusion using the CHOP data, the

jury may confuse the new findings of the plaintiffs’ expert with

the standards from 2001 or 2003. Second, even if the plaintiffs

are willing to pay for the time and effort required to gather,

redact, produce, and interpret the data, the probative value of

this data is disproportionately small in comparison with the

burden that would be placed upon CHOP and Dr. Goin, who are not

parties to this litigation.

For these reasons, the Court will deny the plaintiffs’

motion to compel and will grant the defendants’ motion for a

protective order.

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III. Conclusion

For the foregoing reasons, the defendants’ motion in

limine and motion for a protective order will be granted, and the

plaintiffs’ motion to compel will be denied. The plaintiffs may

not introduce evidence relating to mortality or morbidity at

trial, as explained herein. In addition, the plaintiffs may not

enforce the subpoenas directed to CHOP or Dr. Goin or obtain the

raw data related to the CHOP studies.

An appropriate Order shall issue separately.

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